Actively Recruiting
Safety and Efficacy of CAR T Cell Therapy in Patients with R/r B-ALL
Led by Kara Yakhteh Tajhiz Azma Company · Updated on 2024-10-10
5
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the safety and efficacy of CD19 CAR-T cells in pediatric patients of all genders, aged 2 to 18 years, with relapsing or refractory B cell acute lymphoblastic leukemia (r/r B-ALL). The main questions it aims to answer are as following: 1. What is the percentage of patients with overall remission rate (ORR) of complete response (CR) or complete remission with incomplete blood count recovery (CRi)? 2. What is the rate of Event-free survival at first month and 2-3 months after intervention? 3. What is the rate of Overall survival at first month and at 3 months after the intervention?
CONDITIONS
Official Title
Safety and Efficacy of CAR T Cell Therapy in Patients with R/r B-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 2 to 18 years with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia
- Disease present in the bone marrow
- Able to tolerate the apheresis process
- Life expectancy greater than 12 weeks
- Lansky or Karnofsky performance score greater than 50%
- At least 7 days since last chemotherapy and corticosteroid treatment
- Provided informed consent
- Has a potential donor for stem cell transplantation
You will not qualify if you...
- Active malignancy other than the disease under study
- Chloroma and leukemic infiltration on MRI or significant neurological symptoms
- Any central nervous system disorder
- Presence of active graft versus host disease
- Radiation therapy within the last 14 days
- History of Anti-CD19 or Anti-CD20 therapy
- Donor lymphocyte injection or other cell therapy within the last 30 days
- Presence of severe active infection
- Organ dysfunction
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Pediatric cell and gene therapy research center, Children medical center
Tehran, Tehran Province, Iran, 1419733151
Actively Recruiting
Research Team
S
Setayesh Sadeghi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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